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TPLS as predictive platform for twin-screw wet granulation process and formulation development.

A Ryckaert1, D Van Hauwermeiren2, J Dhondt1

  • 1Laboratory of Pharmaceutical Process Analytical Technology, Department of Pharmaceutical analysis, Ghent University, Ottergemsesteenweg 460, 9000 Ghent, Belgium.

International Journal of Pharmaceutics
|June 10, 2021
PubMed
Summary
This summary is machine-generated.

This study developed a T-shaped partial least squares (TPLS) model to connect raw material properties and process settings to granule quality in twin-screw wet granulation. The model aids in optimizing formulations for new active pharmaceutical ingredients (APIs), reducing development time and API usage.

Keywords:
Continuous manufacturingFormulation developmentProcess understandingTwin-screw granulation

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Area of Science:

  • Pharmaceutical Manufacturing
  • Chemical Engineering
  • Materials Science

Background:

  • Continuous manufacturing, particularly twin-screw wet granulation, is gaining interest in pharmaceutical production.
  • A limited understanding exists regarding how raw material properties and process parameters influence granule quality attributes.
  • Optimizing these factors is crucial for efficient and effective drug product development.

Purpose of the Study:

  • To develop a T-shaped partial least squares (TPLS) model linking raw material properties, formulation composition, and process parameters to granule quality attributes in twin-screw wet granulation.
  • To utilize the TPLS model's predictive capabilities for identifying optimal formulation and process settings for new active pharmaceutical ingredients (APIs).
  • To enhance the understanding of the interdependencies between material characteristics, formulation design, and process variables on final granule properties.

Main Methods:

  • Development of a T-shaped partial least squares (TPLS) model.
  • Analysis of raw material properties, formulation composition (ratios), and twin-screw wet granulation process parameters.
  • Application of the TPLS model for predictive analysis to guide formulation and process development for new APIs.

Main Results:

  • The TPLS model successfully linked raw material properties and process settings to granule quality attributes.
  • The model's predictive ability was demonstrated in identifying suitable conditions for a new API.
  • A better understanding of the relationships governing granule quality was achieved.

Conclusions:

  • The TPLS model provides a valuable tool for understanding and optimizing twin-screw wet granulation processes.
  • This approach can significantly reduce experimental development efforts and the consumption of expensive APIs.
  • It offers a practical starting point for formulation and process development for novel pharmaceutical compounds.